ID

5098

Description

ODM derived from http://clinicaltrials.gov/show/NCT01204710

Link

http://clinicaltrials.gov/show/NCT01204710

Keywords

Versions (3)
  1. 12/7/13 12/7/13 - Martin Dugas
  2. 4/19/14 4/19/14 - Julian Varghese
  3. 9/27/21 9/27/21 -
Uploaded on

April 19, 2014

DOI

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License

Creative Commons BY 4.0
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Eligibility DRKS00003665 NCT01204710 Prostate Cancer

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age at least 18 Years
Description

age at least 18 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
histologically-confirmed adenocarcinoma of the prostate
Description

histologically-confirmed adenocarcinoma of the prostate

Data type

boolean

Alias
UMLS CUI 2011AA
C0205462
SNOMED CT 2011_0131
67151002
UMLS CUI 2011AA
C0750484
UMLS CUI 2011AA
C0007112
SNOMED CT 2011_0131
399490008
MedDRA 14.1
10001186
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
radiographic evidence of metastatic prostate cancer (stage M1 or D2)
Description

radiographic evidence of metastatic prostate cancer (stage M1 or D2)

Data type

boolean

Alias
UMLS CUI 2011AA
C0444708
SNOMED CT 2011_0131
258106000
UMLS CUI 2011AA
C0332120
SNOMED CT 2011_0131
18669006
UMLS CUI 2011AA
C0936223
MedDRA 14.1
10036909
UMLS CUI 2011AA
C0441971
SNOMED CT 2011_0131
55440008
UMLS CUI 2011AA
C0441791
SNOMED CT 2011_0131
261631005
has prostate cancer unresponsive or refractory to medical or surgical castration with a serum testosterone level of < 50 ng/mL
Description

has prostate cancer unresponsive or refractory to medical or surgical castration with a serum testosterone level of < 50 ng/mL

Data type

boolean

Alias
UMLS CUI 2011AA
C0600139
SNOMED CT 2011_0131
254900004
MedDRA 14.1
10036921
UMLS CUI 2011AA
C0205269
SNOMED CT 2011_0131
20646008
UMLS CUI 2011AA
C1513054
UMLS CUI 2011AA
C0007347
SNOMED CT 2011_0131
275234001
UMLS CUI 2011AA
C0428413
SNOMED CT 2011_0131
270973006
MedDRA 14.1
10040409
has had disease progression or intolerance on docetaxel-based therapy
Description

has had disease progression or intolerance on docetaxel-based therapy

Data type

boolean

Alias
UMLS CUI 2011AA
C1947901
UMLS CUI 2011AA
C1744706
UMLS CUI 2011AA
C0699967
SNOMED CT 2011_0131
386918005
UMLS CUI 2011AA
C1705938
UMLS CUI 2011AA
C0039798
Prostate-Specific Antigen
Description

PSA >= 10 ng/mL

Data type

boolean

Alias
UMLS CUI 2011AA
C0138741
SNOMED CT 2011_0131
102687007
LOINC Version 232
MTHU001466
all clinically significant toxic effects of prior surgery, radiotherapy, chemotherapy or hormonal therapy have resolved to <= Grade 1, based on NCI CTCAE v 4.02
Description

all clinically significant toxic effects of prior surgery, radiotherapy, chemotherapy or hormonal therapy have resolved to <= Grade 1, based on NCI CTCAE v 4.02

Data type

boolean

Alias
UMLS CUI 2011AA
C0600688
SNOMED CT 2011_0131
75478009
UMLS CUI 2011AA
C0455610
SNOMED CT 2011_0131
161615003
UMLS CUI 2011AA
CL414551
UMLS CUI 2011AA
C1514457
UMLS CUI 2011AA
C1514460
UMLS CUI 2011AA
C1514893
UMLS CUI 2011AA
C0439090
SNOMED CT 2011_0131
276137008
HL7 V3 2006_05
LE
UMLS CUI 2011AA
C1513302
patient has an ECOG Performance Status 0-2
Description

patient has an ECOG Performance Status 0-2

Data type

boolean

Alias
UMLS CUI 2011AA
C1520224
adequate hematologic function
Description

adequate hematologic function

Data type

boolean

Alias
UMLS CUI 2011AA
C0221130
SNOMED CT 2011_0131
88323005
adequate hepatic function
Description

adequate hepatic function

Data type

boolean

Alias
UMLS CUI 2011AA
C1848676
adequate renal function
Description

adequate renal function

Data type

boolean

Alias
UMLS CUI 2011AA
C0232805
urinary protein is <= 1 on dipstick or routine analysis
Description

urinary protein is <= 1 on dipstick or routine analysis

Data type

boolean

Alias
UMLS CUI 2011AA
C1325413
UMLS CUI 2011AA
C0430370
SNOMED CT 2011_0131
167226008
UMLS CUI 2011AA
C0205547
SNOMED CT 2011_0131
50811001
UMLS CUI 2011AA
C0002778
SNOMED CT 2011_0131
272389005
life expectancy of > 3 months
Description

life expectancy of > 3 months

Data type

boolean

Alias
UMLS CUI 2011AA
C0023671
fertile man with partners that are women of childbearing potential must use an adequate method of contraception during the study
Description

fertile man with partners that are women of childbearing potential must use an adequate method of contraception during the study

Data type

boolean

Alias
UMLS CUI 2011AA
CL426012
UMLS CUI 2011AA
C0025266
SNOMED CT 2011_0131
339947000
UMLS CUI 2011AA
C0682323
SNOMED CT 2011_0131
262043009
HL7 V3 2006_05
SIGOTHR
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0027552
SNOMED CT 2011_0131
410525008
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
signed Informed Consent document
Description

signed Informed Consent document

Data type

boolean

Alias
UMLS CUI 2011AA
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
concurrent active malignancy other than adequately treated nonmelanomatous skin cancer or other noninvasive or in situ neoplasms
Description

concurrent active malignancy other than adequately treated nonmelanomatous skin cancer or other noninvasive or in situ neoplasms

Data type

boolean

Alias
UMLS CUI 2011AA
C0205420
SNOMED CT 2011_0131
68405009
UMLS CUI 2011AA
C0006826
SNOMED CT 2011_0131
363346000
MedDRA 14.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0205411
SNOMED CT 2011_0131
88323005
UMLS CUI 2011AA
CL415147
UMLS CUI 2011AA
C0699893
MedDRA 14.1
10040810
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0007099
SNOMED CT 2011_0131
109355002
MedDRA 14.1
10061450
ICD-10-CM Version 2010
D09.9
ICD-9-CM Version 2011
234.9
The patient has received more than 1 prior cytotoxic chemotherapy regimen for metastatic disease
Description

The patient has received more than 1 prior cytotoxic chemotherapy regimen for metastatic disease

Data type

boolean

Alias
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C0439093
SNOMED CT 2011_0131
276140008
HL7 V3 2006_05
GT
UMLS CUI 2011AA
C0205447
SNOMED CT 2011_0131
38112003
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0677881
UMLS CUI 2011AA
C0027627
MedDRA 14.1
10027478
prior therapy with mitoxantrone for advanced prostate cancer
Description

prior therapy with mitoxantrone for advanced prostate cancer

Data type

boolean

Alias
UMLS CUI 2011AA
C1514463
UMLS CUI 2011AA
C0026259
SNOMED CT 2011_0131
386913001
UMLS CUI 2011AA
C0205179
SNOMED CT 2011_0131
86005002
UMLS CUI 2011AA
C0600139
SNOMED CT 2011_0131
254900004
MedDRA 14.1
10036921
The patient has a history of symptomatic congestive heart failure or has a pre study echocardiogram or multigated acquisition scan with left ventricular ejection fraction that is >= 10% below the lower limit of normal institutional range
Description

The patient has a history of symptomatic congestive heart failure or has a pre study echocardiogram or multigated acquisition scan with left ventricular ejection fraction that is >= 10% below the lower limit of normal institutional range

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0018802
SNOMED CT 2011_0131
42343007
MedDRA 14.1
10007559
LOINC Version 232
MTHU020787
ICD-10-CM Version 2010
I50.9
ICD-9-CM Version 2011
428.0
UMLS CUI 2011AA
C2243117
UMLS CUI 2011AA
C0521317
SNOMED CT 2011_0131
404221001
MedDRA 14.1
10028211
UMLS CUI 2011AA
C0428772
SNOMED CT 2011_0131
250908004
MedDRA 14.1
10069170
UMLS CUI 2011AA
C1518030
history of prior treatment with other agents that directly inhibit PDGF or platelet-derived growth factor receptors
Description

history of prior treatment with other agents that directly inhibit PDGF or platelet-derived growth factor receptors

Data type

boolean

Alias
UMLS CUI 2011AA
C1514463
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C1254351
UMLS CUI 2011AA
C0021469
SNOMED CT 2011_0131
61511001
UMLS CUI 2011AA
C0032200
SNOMED CT 2011_0131
10987005
UMLS CUI 2011AA
C0071253
known allergy to any of the treatment components: IMC 3G3, mitoxantrone, and/or prednisone
Description

known allergy to any of the treatment components: IMC 3G3, mitoxantrone, and/or prednisone

Data type

boolean

Alias
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
257550005
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C1705248
UMLS CUI 2011AA
C2703171
UMLS CUI 2011AA
C0026259
SNOMED CT 2011_0131
386913001
UMLS CUI 2011AA
C0032952
SNOMED CT 2011_0131
116602009
LOINC Version 232
MTHU003245
radiotherapy within 21 days prior to first dose of IMC-3G3
Description

radiotherapy within 21 days prior to first dose of IMC-3G3

Data type

boolean

Alias
UMLS CUI 2011AA
C0034619
UMLS CUI 2011AA
C0205449
SNOMED CT 2011_0131
421291004
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0205435
SNOMED CT 2011_0131
255216001
UMLS CUI 2011AA
C0178602
SNOMED CT 2011_0131
260911001
UMLS CUI 2011AA
C2703171
any investigational therapy within 30 days of randomization
Description

any investigational therapy within 30 days of randomization

Data type

boolean

Alias
UMLS CUI 2011AA
C0949266
UMLS CUI 2011AA
C0205447
SNOMED CT 2011_0131
38112003
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C0034656
is receiving corticosteroids at a dose > 5 mg prednisone orally (PO) 2 times per day (BID) or equivalent
Description

is receiving corticosteroids at a dose > 5 mg prednisone orally (PO) 2 times per day (BID) or equivalent

Data type

boolean

Alias
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C0001617
SNOMED CT 2011_0131
79440004
UMLS CUI 2011AA
C0178602
SNOMED CT 2011_0131
260911001
UMLS CUI 2011AA
C0439093
SNOMED CT 2011_0131
276140008
HL7 V3 2006_05
GT
UMLS CUI 2011AA
C0520151
UMLS CUI 2011AA
C0585361
SNOMED CT 2011_0131
229799001
HL7 V3 2006_05
BID
UMLS CUI 2011AA
CL415123
received prior strontium-89, rhenium-186, rhenium-188, or samarium-153 radionucleotide therapy and has either ongoing evidence of bone marrow dysfunction or poorly controlled bone pain
Description

received prior strontium-89, rhenium-186, rhenium-188, or samarium-153 radionucleotide therapy and has either ongoing evidence of bone marrow dysfunction or poorly controlled bone pain

Data type

boolean

Alias
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0281385
SNOMED CT 2011_0131
7770004
UMLS CUI 2011AA
C0361302
SNOMED CT 2011_0131
353644005
UMLS CUI 2011AA
C1828331
SNOMED CT 2011_0131
423578007
UMLS CUI 2011AA
C0677942
SNOMED CT 2011_0131
419804008
UMLS CUI 2011AA
C0203608
SNOMED CT 2011_0131
399315003
UMLS CUI 2011AA
C0005953
SNOMED CT 2011_0131
14016003
LOINC Version 232
MTHU016536
UMLS CUI 2011AA
C0277785
SNOMED CT 2011_0131
386585008
UMLS CUI 2011AA
C0205169
SNOMED CT 2011_0131
556001
UMLS CUI 2011AA
C2587213
SNOMED CT 2011_0131
31509003
UMLS CUI 2011AA
C0151825
SNOMED CT 2011_0131
12584003
MedDRA 14.1
10006002
LOINC Version 232
MTHU020858
CTCAE 1105E
E12392
has any ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia, psychiatric illness, active bleeding or pathological condition that carries a high risk of bleeding, or any other serious uncontrolled medical disorders
Description

has any ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia, psychiatric illness, active bleeding or pathological condition that carries a high risk of bleeding, or any other serious uncontrolled medical disorders

Data type

boolean

Alias
UMLS CUI 2011AA
C0021311
SNOMED CT 2011_0131
257551009
MedDRA 14.1
10021789
UMLS CUI 2011AA
C0018802
SNOMED CT 2011_0131
42343007
MedDRA 14.1
10007559
LOINC Version 232
MTHU020787
ICD-10-CM Version 2010
I50.9
ICD-9-CM Version 2011
428.0
UMLS CUI 2011AA
C0002965
SNOMED CT 2011_0131
4557003
MedDRA 14.1
10002388
ICD-10-CM Version 2010
I20.0
ICD-9-CM Version 2011
411.1
UMLS CUI 2011AA
C0003811
SNOMED CT 2011_0131
44808001
MedDRA 14.1
10003119
ICD-9-CM Version 2011
427.9
UMLS CUI 2011AA
C0004936
SNOMED CT 2011_0131
74732009
MedDRA 14.1
10037174
ICD-10-CM Version 2010
F99
ICD-9-CM Version 2011
290-319.99
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C0332167
SNOMED CT 2011_0131
15508007
UMLS CUI 2011AA
C0019080
SNOMED CT 2011_0131
50960005
MedDRA 14.1
10055798
ICD-10-CM Version 2010
R58
ICD-9-CM Version 2011
459.0
UMLS CUI 2011AA
C0205318
SNOMED CT 2011_0131
19032002
UMLS CUI 2011AA
C0205476
SNOMED CT 2011_0131
74188005
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
known or suspected brain or leptomeningeal metastases
Description

known or suspected brain or leptomeningeal metastases

Data type

boolean

Alias
UMLS CUI 2011AA
C0220650
MedDRA 14.1
10006128
UMLS CUI 2011AA
CL411846
MedDRA 14.1
10051696
known human immunodeficiency virus infection or acquired immunodeficiency syndrome-related illness
Description

known human immunodeficiency virus infection or acquired immunodeficiency syndrome-related illness

Data type

boolean

Alias
UMLS CUI 2011AA
C0019693
SNOMED CT 2011_0131
86406008
MedDRA 14.1
10020161
LOINC Version 232
MTHU020829
ICD-10-CM Version 2010
B20
ICD-9-CM Version 2011
042
UMLS CUI 2011AA
C0877121
MedDRA 14.1
10061624
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age at least 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
histologically-confirmed adenocarcinoma of the prostate
Item
histologically-confirmed adenocarcinoma of the prostate
boolean
C0205462 (UMLS CUI 2011AA)
67151002 (SNOMED CT 2011_0131)
C0750484 (UMLS CUI 2011AA)
C0007112 (UMLS CUI 2011AA)
399490008 (SNOMED CT 2011_0131)
10001186 (MedDRA 14.1)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
radiographic evidence of metastatic prostate cancer (stage M1 or D2)
Item
radiographic evidence of metastatic prostate cancer (stage M1 or D2)
boolean
C0444708 (UMLS CUI 2011AA)
258106000 (SNOMED CT 2011_0131)
C0332120 (UMLS CUI 2011AA)
18669006 (SNOMED CT 2011_0131)
C0936223 (UMLS CUI 2011AA)
10036909 (MedDRA 14.1)
C0441971 (UMLS CUI 2011AA)
55440008 (SNOMED CT 2011_0131)
C0441791 (UMLS CUI 2011AA)
261631005 (SNOMED CT 2011_0131)
has prostate cancer unresponsive or refractory to medical or surgical castration with a serum testosterone level of < 50 ng/mL
Item
has prostate cancer unresponsive or refractory to medical or surgical castration with a serum testosterone level of < 50 ng/mL
boolean
C0600139 (UMLS CUI 2011AA)
254900004 (SNOMED CT 2011_0131)
10036921 (MedDRA 14.1)
C0205269 (UMLS CUI 2011AA)
20646008 (SNOMED CT 2011_0131)
C1513054 (UMLS CUI 2011AA)
C0007347 (UMLS CUI 2011AA)
275234001 (SNOMED CT 2011_0131)
C0428413 (UMLS CUI 2011AA)
270973006 (SNOMED CT 2011_0131)
10040409 (MedDRA 14.1)
has had disease progression or intolerance on docetaxel-based therapy
Item
has had disease progression or intolerance on docetaxel-based therapy
boolean
C1947901 (UMLS CUI 2011AA)
C1744706 (UMLS CUI 2011AA)
C0699967 (UMLS CUI 2011AA)
386918005 (SNOMED CT 2011_0131)
C1705938 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
PSA >= 10 ng/mL
Item
Prostate-Specific Antigen
boolean
C0138741 (UMLS CUI 2011AA)
102687007 (SNOMED CT 2011_0131)
MTHU001466 (LOINC Version 232)
all clinically significant toxic effects of prior surgery, radiotherapy, chemotherapy or hormonal therapy have resolved to <= Grade 1, based on NCI CTCAE v 4.02
Item
all clinically significant toxic effects of prior surgery, radiotherapy, chemotherapy or hormonal therapy have resolved to <= Grade 1, based on NCI CTCAE v 4.02
boolean
C0600688 (UMLS CUI 2011AA)
75478009 (SNOMED CT 2011_0131)
C0455610 (UMLS CUI 2011AA)
161615003 (SNOMED CT 2011_0131)
CL414551 (UMLS CUI 2011AA)
C1514457 (UMLS CUI 2011AA)
C1514460 (UMLS CUI 2011AA)
C1514893 (UMLS CUI 2011AA)
C0439090 (UMLS CUI 2011AA)
276137008 (SNOMED CT 2011_0131)
LE (HL7 V3 2006_05)
C1513302 (UMLS CUI 2011AA)
patient has an ECOG Performance Status 0-2
Item
patient has an ECOG Performance Status 0-2
boolean
C1520224 (UMLS CUI 2011AA)
adequate hematologic function
Item
adequate hematologic function
boolean
C0221130 (UMLS CUI 2011AA)
88323005 (SNOMED CT 2011_0131)
adequate hepatic function
Item
adequate hepatic function
boolean
C1848676 (UMLS CUI 2011AA)
adequate renal function
Item
adequate renal function
boolean
C0232805 (UMLS CUI 2011AA)
urinary protein is <= 1 on dipstick or routine analysis
Item
urinary protein is <= 1 on dipstick or routine analysis
boolean
C1325413 (UMLS CUI 2011AA)
C0430370 (UMLS CUI 2011AA)
167226008 (SNOMED CT 2011_0131)
C0205547 (UMLS CUI 2011AA)
50811001 (SNOMED CT 2011_0131)
C0002778 (UMLS CUI 2011AA)
272389005 (SNOMED CT 2011_0131)
life expectancy of > 3 months
Item
life expectancy of > 3 months
boolean
C0023671 (UMLS CUI 2011AA)
fertile man with partners that are women of childbearing potential must use an adequate method of contraception during the study
Item
fertile man with partners that are women of childbearing potential must use an adequate method of contraception during the study
boolean
CL426012 (UMLS CUI 2011AA)
C0025266 (UMLS CUI 2011AA)
339947000 (SNOMED CT 2011_0131)
C0682323 (UMLS CUI 2011AA)
262043009 (SNOMED CT 2011_0131)
SIGOTHR (HL7 V3 2006_05)
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0027552 (UMLS CUI 2011AA)
410525008 (SNOMED CT 2011_0131)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
signed Informed Consent document
Item
signed Informed Consent document
boolean
C0021430 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
concurrent active malignancy other than adequately treated nonmelanomatous skin cancer or other noninvasive or in situ neoplasms
Item
concurrent active malignancy other than adequately treated nonmelanomatous skin cancer or other noninvasive or in situ neoplasms
boolean
C0205420 (UMLS CUI 2011AA)
68405009 (SNOMED CT 2011_0131)
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
CL411789 (UMLS CUI 2011AA)
C0205411 (UMLS CUI 2011AA)
88323005 (SNOMED CT 2011_0131)
CL415147 (UMLS CUI 2011AA)
C0699893 (UMLS CUI 2011AA)
10040810 (MedDRA 14.1)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0007099 (UMLS CUI 2011AA)
109355002 (SNOMED CT 2011_0131)
10061450 (MedDRA 14.1)
D09.9 (ICD-10-CM Version 2010)
234.9 (ICD-9-CM Version 2011)
The patient has received more than 1 prior cytotoxic chemotherapy regimen for metastatic disease
Item
The patient has received more than 1 prior cytotoxic chemotherapy regimen for metastatic disease
boolean
C1514756 (UMLS CUI 2011AA)
C0439093 (UMLS CUI 2011AA)
276140008 (SNOMED CT 2011_0131)
GT (HL7 V3 2006_05)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0677881 (UMLS CUI 2011AA)
C0027627 (UMLS CUI 2011AA)
10027478 (MedDRA 14.1)
prior therapy with mitoxantrone for advanced prostate cancer
Item
prior therapy with mitoxantrone for advanced prostate cancer
boolean
C1514463 (UMLS CUI 2011AA)
C0026259 (UMLS CUI 2011AA)
386913001 (SNOMED CT 2011_0131)
C0205179 (UMLS CUI 2011AA)
86005002 (SNOMED CT 2011_0131)
C0600139 (UMLS CUI 2011AA)
254900004 (SNOMED CT 2011_0131)
10036921 (MedDRA 14.1)
The patient has a history of symptomatic congestive heart failure or has a pre study echocardiogram or multigated acquisition scan with left ventricular ejection fraction that is >= 10% below the lower limit of normal institutional range
Item
The patient has a history of symptomatic congestive heart failure or has a pre study echocardiogram or multigated acquisition scan with left ventricular ejection fraction that is >= 10% below the lower limit of normal institutional range
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0018802 (UMLS CUI 2011AA)
42343007 (SNOMED CT 2011_0131)
10007559 (MedDRA 14.1)
MTHU020787 (LOINC Version 232)
I50.9 (ICD-10-CM Version 2010)
428.0 (ICD-9-CM Version 2011)
C2243117 (UMLS CUI 2011AA)
C0521317 (UMLS CUI 2011AA)
404221001 (SNOMED CT 2011_0131)
10028211 (MedDRA 14.1)
C0428772 (UMLS CUI 2011AA)
250908004 (SNOMED CT 2011_0131)
10069170 (MedDRA 14.1)
C1518030 (UMLS CUI 2011AA)
history of prior treatment with other agents that directly inhibit PDGF or platelet-derived growth factor receptors
Item
history of prior treatment with other agents that directly inhibit PDGF or platelet-derived growth factor receptors
boolean
C1514463 (UMLS CUI 2011AA)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C1254351 (UMLS CUI 2011AA)
C0021469 (UMLS CUI 2011AA)
61511001 (SNOMED CT 2011_0131)
C0032200 (UMLS CUI 2011AA)
10987005 (SNOMED CT 2011_0131)
C0071253 (UMLS CUI 2011AA)
known allergy to any of the treatment components: IMC 3G3, mitoxantrone, and/or prednisone
Item
known allergy to any of the treatment components: IMC 3G3, mitoxantrone, and/or prednisone
boolean
C0020517 (UMLS CUI 2011AA)
257550005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0039798 (UMLS CUI 2011AA)
C1705248 (UMLS CUI 2011AA)
C2703171 (UMLS CUI 2011AA)
C0026259 (UMLS CUI 2011AA)
386913001 (SNOMED CT 2011_0131)
C0032952 (UMLS CUI 2011AA)
116602009 (SNOMED CT 2011_0131)
MTHU003245 (LOINC Version 232)
radiotherapy within 21 days prior to first dose of IMC-3G3
Item
radiotherapy within 21 days prior to first dose of IMC-3G3
boolean
C0034619 (UMLS CUI 2011AA)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0205435 (UMLS CUI 2011AA)
255216001 (SNOMED CT 2011_0131)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C2703171 (UMLS CUI 2011AA)
any investigational therapy within 30 days of randomization
Item
any investigational therapy within 30 days of randomization
boolean
C0949266 (UMLS CUI 2011AA)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0034656 (UMLS CUI 2011AA)
is receiving corticosteroids at a dose > 5 mg prednisone orally (PO) 2 times per day (BID) or equivalent
Item
is receiving corticosteroids at a dose > 5 mg prednisone orally (PO) 2 times per day (BID) or equivalent
boolean
C1514756 (UMLS CUI 2011AA)
C0001617 (UMLS CUI 2011AA)
79440004 (SNOMED CT 2011_0131)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0439093 (UMLS CUI 2011AA)
276140008 (SNOMED CT 2011_0131)
GT (HL7 V3 2006_05)
C0520151 (UMLS CUI 2011AA)
C0585361 (UMLS CUI 2011AA)
229799001 (SNOMED CT 2011_0131)
BID (HL7 V3 2006_05)
CL415123 (UMLS CUI 2011AA)
received prior strontium-89, rhenium-186, rhenium-188, or samarium-153 radionucleotide therapy and has either ongoing evidence of bone marrow dysfunction or poorly controlled bone pain
Item
received prior strontium-89, rhenium-186, rhenium-188, or samarium-153 radionucleotide therapy and has either ongoing evidence of bone marrow dysfunction or poorly controlled bone pain
boolean
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0281385 (UMLS CUI 2011AA)
7770004 (SNOMED CT 2011_0131)
C0361302 (UMLS CUI 2011AA)
353644005 (SNOMED CT 2011_0131)
C1828331 (UMLS CUI 2011AA)
423578007 (SNOMED CT 2011_0131)
C0677942 (UMLS CUI 2011AA)
419804008 (SNOMED CT 2011_0131)
C0203608 (UMLS CUI 2011AA)
399315003 (SNOMED CT 2011_0131)
C0005953 (UMLS CUI 2011AA)
14016003 (SNOMED CT 2011_0131)
MTHU016536 (LOINC Version 232)
C0277785 (UMLS CUI 2011AA)
386585008 (SNOMED CT 2011_0131)
C0205169 (UMLS CUI 2011AA)
556001 (SNOMED CT 2011_0131)
C2587213 (UMLS CUI 2011AA)
31509003 (SNOMED CT 2011_0131)
C0151825 (UMLS CUI 2011AA)
12584003 (SNOMED CT 2011_0131)
10006002 (MedDRA 14.1)
MTHU020858 (LOINC Version 232)
E12392 (CTCAE 1105E)
has any ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia, psychiatric illness, active bleeding or pathological condition that carries a high risk of bleeding, or any other serious uncontrolled medical disorders
Item
has any ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia, psychiatric illness, active bleeding or pathological condition that carries a high risk of bleeding, or any other serious uncontrolled medical disorders
boolean
C0021311 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C0018802 (UMLS CUI 2011AA)
42343007 (SNOMED CT 2011_0131)
10007559 (MedDRA 14.1)
MTHU020787 (LOINC Version 232)
I50.9 (ICD-10-CM Version 2010)
428.0 (ICD-9-CM Version 2011)
C0002965 (UMLS CUI 2011AA)
4557003 (SNOMED CT 2011_0131)
10002388 (MedDRA 14.1)
I20.0 (ICD-10-CM Version 2010)
411.1 (ICD-9-CM Version 2011)
C0003811 (UMLS CUI 2011AA)
44808001 (SNOMED CT 2011_0131)
10003119 (MedDRA 14.1)
427.9 (ICD-9-CM Version 2011)
C0004936 (UMLS CUI 2011AA)
74732009 (SNOMED CT 2011_0131)
10037174 (MedDRA 14.1)
F99 (ICD-10-CM Version 2010)
290-319.99 (ICD-9-CM Version 2011)
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0332167 (UMLS CUI 2011AA)
15508007 (SNOMED CT 2011_0131)
C0019080 (UMLS CUI 2011AA)
50960005 (SNOMED CT 2011_0131)
10055798 (MedDRA 14.1)
R58 (ICD-10-CM Version 2010)
459.0 (ICD-9-CM Version 2011)
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0205476 (UMLS CUI 2011AA)
74188005 (SNOMED CT 2011_0131)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
known or suspected brain or leptomeningeal metastases
Item
known or suspected brain or leptomeningeal metastases
boolean
C0220650 (UMLS CUI 2011AA)
10006128 (MedDRA 14.1)
CL411846 (UMLS CUI 2011AA)
10051696 (MedDRA 14.1)
known human immunodeficiency virus infection or acquired immunodeficiency syndrome-related illness
Item
known human immunodeficiency virus infection or acquired immunodeficiency syndrome-related illness
boolean
C0019693 (UMLS CUI 2011AA)
86406008 (SNOMED CT 2011_0131)
10020161 (MedDRA 14.1)
MTHU020829 (LOINC Version 232)
B20 (ICD-10-CM Version 2010)
042 (ICD-9-CM Version 2011)
C0877121 (UMLS CUI 2011AA)
10061624 (MedDRA 14.1)
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